Actively Recruiting
A Study of Bupivacaine Liposome Injection in Local Analgesia of Pediatric Patients
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2025-10-02
232
Participants Needed
1
Research Sites
124 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is being conducted to evaluate the safety and efficacy of bupivacaine liposome injection for local infiltration analgesia in pediatric orthopedic surgery in the real world.
CONDITIONS
Official Title
A Study of Bupivacaine Liposome Injection in Local Analgesia of Pediatric Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects and guardians are willing to sign the informed consent.
- Subjects undergoing orthopedic surgery under general anesthesia with expected cumulative incision length 23 cm.
- Age between 6 and 17 years, male or female.
- ASA Physical Status Classification I-III.
You will not qualify if you...
- Received liposomal bupivacaine or bupivacaine hydrochloride within the past 30 days.
- History of immunodeficiency diseases or use of immunosuppressants within 30 days.
- Comorbid mental diseases or difficulty communicating.
- History of chronic pain or visceral pain.
- Abnormal liver or kidney function.
- Clinically significant abnormal heart rate or rhythm.
- Currently participating or planning to participate in any interventional clinical trial.
- Other conditions deemed inappropriate by investigators for participation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
T
Thea Yu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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